Comparing Intubating Conditions Using Succinylcholine or Rocuronium for Rigid Bronchoscopy

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Dr. Horst Schmidt Klinik GmbH
Sponsor:
Information provided by (Responsible Party):
Prof. Grietje Beck, Dr. Horst Schmidt Klinik GmbH
ClinicalTrials.gov Identifier:
NCT01996358
First received: November 22, 2013
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

Succinylcholine is commonly used for neuromuscular relaxation for short procedures such as rigid bronchoscopy. A more modern alternative is the application aof rocuronium, reversed by sugammadex. The investigators compare the intubating conditions, incidence of postoperative myalgia (POM) as well as patient satisfaction for these two muscle relaxants.


Condition Intervention
Intubating Conditions
Postoperative Myalgia
Patient Satisfaction
Drug: Succinylcholine
Drug: Rocuronium 0,3
Drug: Rocuronium 0,6

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparing Intubating Conditions Using Succinylcholine or Rocuronium/Sugammadex for Rigid Bronchoscopy: a Randomized Study

Resource links provided by NLM:


Further study details as provided by Dr. Horst Schmidt Klinik GmbH:

Primary Outcome Measures:
  • Intubating Condition [ Time Frame: after induction of general anaesthesia (after 3-5 minutes) ] [ Designated as safety issue: No ]
    The intubating conditions will be measured using the scoring system proposed for Good Clinical Research Practice using the following variables: conditions of inserting the rigid bronchoscope, vocal cord position and coughing


Secondary Outcome Measures:
  • Postoperative Myalgia [ Time Frame: 72 hours after intervention ] [ Designated as safety issue: No ]

    The severity of POM is measured by using a four-point-scale:

    0. no myalgia

    1. minor pain limited to one area of the body
    2. muscle pain or stiffness noticed spontaneously by the patient, which may have required analgesic therapy
    3. generalized, severe or incapacitating discomfort


Other Outcome Measures:
  • Patient satisfaction [ Time Frame: 72 hours after intervention ] [ Designated as safety issue: No ]
    measurement on a numeric ten point scale


Estimated Enrollment: 150
Study Start Date: September 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Succinylcholine
Succinylcholine 0,5mg/kg as muscle relaxant during induction of anaesthesia for rigid bronchoscopy
Drug: Succinylcholine
Anaesthesia is induced and maintained with propofol (1-2 mg/kg) and remifentanil (0,5 µg/kg). The study arm is immobilized and after cleaning the skin a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. After induction of anaesthesia the patient receives muscle relaxant according to the study group.
Active Comparator: Rocuronium 0,3
Rocuronium 0,3 mg/kg during induction of anaesthesia for rigid bronchoscopy. At the end of procedure 2mg/kg sugammadex for reversal of neuromuscular block are applied.
Drug: Rocuronium 0,3
General anaesthesia is induced and maintained with propofol (1-2mg/kg) and remifentanil (0,5µg/kg). The study arm is immobilized and after cleaning the skin a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. The Patient receives the muscle relaxant according to the study group.
Active Comparator: Rocuronium 0,6
Rocuronium 0,6 mg/kg during induction of anaesthesia for rigid bronchoscopy. At the end of procedure 2mg/kg sugammadex for reversal of neuromuscular block are applied.
Drug: Rocuronium 0,6
General anaesthesia is induced and maintained with propofol (1-2mg/kg) and remifentanil (0,5µg/kg). The study arm is immobilized and after cleaning the skin a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. The Patient receives the muscle relaxant according to the study group.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age > 18 yr
  • scheduled for elective rigid bronchoscopy

Exclusion Criteria:

  • known neuromuscular disease
  • significant hepatic or renal dysfunction
  • family history of malignant hyperthermia
  • known allergy to one of the drugs used in this protocol
  • pregnancy or breastfeeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01996358

Contacts
Contact: Grietje Beck, Prof 0049 611 432176 grietje.beck@hsk-wiesbaden.de
Contact: Verena Ghezel-Ahmadi, Dr 0049 611 432176 verena.ghezel-ahmadi@hsk-wiesbaden.de

Locations
Germany
Dr. Horst Schmidt Klinik Not yet recruiting
Wiesbaden, Hessen, Germany, 65199
Contact: Grietje Beck, Prof    0049 611 432176      
Principal Investigator: Verena Ghezel-Ahmadi, Dr         
Sponsors and Collaborators
Dr. Horst Schmidt Klinik GmbH
Investigators
Study Chair: Grietje Beck, Prof Dr. Horst Schmidt Klinik
  More Information

No publications provided

Responsible Party: Prof. Grietje Beck, Professor Dr. med, Dr. Horst Schmidt Klinik GmbH
ClinicalTrials.gov Identifier: NCT01996358     History of Changes
Other Study ID Numbers: HSK004
Study First Received: November 22, 2013
Last Updated: August 1, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dr. Horst Schmidt Klinik GmbH:
Succinylcholine
Rocuronium
Rigid Bronchoscopy

Additional relevant MeSH terms:
Disease
Pathologic Processes
Rocuronium
Succinylcholine
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Neuromuscular Depolarizing Agents

ClinicalTrials.gov processed this record on October 01, 2014